Generic PrEP Bought Online 'Contains Correct Amount of Drug'

Heather Boerner

November 01, 2018

GLASGOW — For physicians worried about what their patients may be getting when they order HIV prevention pills online, Dr Marta Boffito, Chelsea and Westminster Hospital, London, has one thing to say: "There's no need to worry."

A blinded analysis of nine different formulations of the HIV prevention drug therapy (PrEP) tenofovir/emtracitabine (TDF/FTC, Truvada, Gilead Sciences) manufactured by nine companies, including Gilead Sciences, found that the tablets did indeed contain equivalent amounts of active drugs, and none were counterfeit.

"This should reassure physicians that their patients are taking the right drug," she said.

"They need to support their patients with the different scheduled appointments and adherence, but they shouldn't worry in case the person becomes HIV positive," she said, because the drugs tested did contain enough of the active ingredients.

Dispelling Rumours

Currently, the only TDF/FTC that's available through the NHS in England comes through the IMPACT study. The HIV organisation Terrence Higgins Trust says 42% of those accessing PrEP in England source outside of the NHS trial, including online purchases.

Scotland and Wales made PrEP generally available in the summer of 2018.

Two years ago, Dr Nneka Nwokolo, of the HIV and Sexual Health Clinic, Dean St. in London, and colleagues, including Boffito, took blood from 293 people using online TDF/FTC for HIV prevention and tested plasma concentration of the two drugs. In every participant drug levels were above plasma concentrations needed for protection.

"We thought our job was done," said Boffito.

But then they started to receive calls from advocates and others in Europe, raising concerns, not that the drugs didn't work, but that the pills "didn't contain the drug". In other words, they were worried that patients were getting counterfeits.

So Boffito and team decided to try again. They determined the most popular brands and formulations being purchased online in England using the expertise of Dr Will Nutland, of the London School of Hygiene and Tropical Medicine, and founder of the website PrEPster. Then, the team went out and ordered the tablets themselves.

Online suppliers were not told about the test purchases taking place. They also acquired branded Truvada from the NHS and included the generic pills manufactured by Mylan and being used by the IMPACT trial for its participants.

"We decided, 'Let's use both in case of variations,'" she said.

Then, the pills were removed from their containers and the investigators blinded from the manufacturers. Next it was just a matter of crushing up the pills in a mortar and pestle to a fine powder and applying a solvent to tease out how much active drug the pills actually contained.

"I wish all research were this easy," Boffito joked.

Right Drug, Effective Amounts 

Their data were presented at the HIV Drug Therapy Conference at Glasgow’s SEC and show all the PrEP tablets contained between 94.3% to 104.9% of the 300 mg of tenofovir disoproxil fumarate stated on the label, and between 97.3% to 104.4% of the 200 mg emtricitabine claimed on the packaging.

But all of them, Boffito said, contained the right drug and an effective amount of the drug.

"We weren't very worried, to be honest with you, about what happens in England, because so many people are using PrEP this way," she said. "Different countries may have access to different generic drugs. For us in England, it is really important that people are reassured that they are taking the right drug."

Ian Green, Terrence Higgins Trust chief executive commented in a statement: "These results clearly show that the PrEP being privately sourced online from the main suppliers is fit for purpose and therefore, when taken as prescribed, highly effective at preventing HIV. Understandably, those considering ordering PrEP online have some concerns about what they are buying and hopefully this will act as further reassurance.

"But this doesn’t change the fact that NHS England must make PrEP routinely available to those who need it. It’s unacceptable that many trial sites on the IMPACT Trial are now unable to provide PrEP for gay and bisexual men as no-one should be denied a pill which can prevent HIV as we work toward reaching zero HIV transmissions in this country."

The Terrence Higgins Trust funded this study. Boffito reports receiving honoraria and speaking fees from Janssen, ViiV Healthcare, Gilead Sciences, Cipla, BMS, Teva and Merck Sharp & Dohme. 

HIV Drug Treatment 2018. P010. Presented Oct. 28, 2018.

Editor's Note, 23rd April 2019: Part of this article was edited for clarity.

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